Form No. 2 Consent Form

Safety Impacts of Human-Automated Driving System (ADS) Team Driving Applications

Attachment H - ICF 3.29.24

OMB: 2126-0083

Document [pdf]
Download: pdf | pdf
OMB Control No.: 2126-00XX
Expiration Date: MM/DD/YYYY
Public Burden Statement
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of information displays a current
valid OMB Control number. The OMB Control number for this information collection is 2126-00XX.
Public reporting for this collection of information is estimated to be approximately 15 minutes per
response, including the time for reviewing instructions, gathering the data needed, and completing and
reviewing the collection of information. All responses to this collection of information are voluntary.
Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to brian.routhier@dot.gov.

VIRGINIA POLYTECHNIC INSTITUTE AND STATE UNIVERSITY

Consent to Take Part in a Research Study
Title of research study: Safety Impacts of Human-ADS Team Driving Applications for CMVs
(IRB #23-238)

Principal Investigator: Matthew Camden, mcamden@vtti.vt.edu, 540-231-1503
Other Study Contacts: Andrew Krum, akrum@vtti.vt.edu, 540-231-0353
Key Information: The following is a short summary of this study to help you decide whether to be
a part of this study. More detailed information is listed later in this form.

Why am I being invited to take part in a research study?
We invite you to take part in this research study because you are 21 years of age or older and have a
Class A or Class B CDL.

What should I know about being in a research study?
•
•
•
•
•
•

Someone will explain this research study to you.
Participation is optional.
The video, other data, and additional information that could be used to identify you will be held
under a high level of security.
Your data will not be linked to your name or identity.
If you decide to take part, you are always free to change your mind and exit the study at any
point without penalty.
You are welcome to ask all the questions you want before you decide.

Why is this research being done?
This simulator study seeks to understand situations where a human will team with an automated
commercial motor vehicle (CMV). This research will evaluate the safety of these driver-automated
CMV teams. Data from this study will be used in a confidential way to understand automated driving
systems in CMVs.

How long will the research last?
Participation in the study will last a total of 17 hours.

What will I need to do if I choose to participate?
If you choose to participate, you will need to do the following:
1. Come to VTTI in Blacksburg, Virginia for one 17-hour session, including extended breaks.
2. Complete several questionnaires that will gather information about you, your driving history,
and your thoughts on different in-vehicle technologies.

Virginia Tech Institutional Review Board Protocol No. 23-238
Approved March 7, 2023

1 of 6

Consent to Take Part in a Research Study
3. “Drive” in a driving simulator while teaming with an automated CMV.
4. Let the experimenter know if you begin to experience any nausea, dizziness, or other symptoms
that sometimes occur when driving in a simulator.
5. Agree to have VTTI pick you up and take you home, or pay for a rideshare if you live within
30 miles of VTTI, or agree to have VTTI pay for one night in a local hotel if you live more than
30 miles away from VTTI (we will pick you up and drop you off from the hotel and transport
you to VTTI). Due to the extended participation time, we will not allow participants to drive
themselves home after the study, for safety reasons.

Is there any way being in this study could be bad for me?
You may experience symptoms of “simulator sickness” including dizziness and nausea. More detailed
information about the risks of this study can be found under “Is there any way being in this study
could be bad for me? (Detailed Risks)”.

Will being in this study help me in any way?
There are no benefits to you from taking part in this research.

What happens if I do not want to be in this research?
Taking part in this research is completely up to you. You can decide to participate or not to
participate.

Detailed Information: The following is more detailed information about this study in addition to
the information listed above.

Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, talk to Matt
Camden at (540) 231-1503 or email him at: mcamden@vtti.vt.edu
This research has been reviewed and approved by the Virginia Tech Institutional Review Board
(IRB). You may communicate with them at 540-231-3732 or irb@vt.edu if:
•
•
•
•

You have questions about your rights as a research subject
Your questions, concerns, or complaints are not being answered by the research team
You cannot reach the research team
You want to talk to someone besides the research team to provide feedback about this
research

How many people will be studied?
We plan to include about 80 people in this research study.

What happens if I say yes, I want to be in this research?
If you agree to participate in this study, you will be asked to come to VTTI to participate in a 17hour session. During this session you will:

Virginia Tech Institutional Review Board Protocol No. 23-238
Approved March 7, 2023

VT SBE Informed Consent version 1.0.0
2 of 6

Consent to Take Part in a Research Study
1. Read and sign this Informed Consent Form.
2. Fill out a W9 form for compensation purposes.
3. Complete a Pre-Study Demographics questionnaire, Perceptions of Technology & Vehicle
ADS questionnaire, and Pre-Study Driver Behavior questionnaire.
4. Complete a Psycho-motor vigilance test (PVT) that requires you to use a VTTI tablet and
tap the screen when you see a counter appear at random intervals during a 3-minute test.
This test measures your reaction time.
5. Complete a short training on the driving simulator. After which you will complete a motion
sickness questionnaire to understand how the simulator affects you.
6. “Drive” in the simulator for approximately 16 hours where you will transition from being in
control of the CMV to allowing the automated CMV to be in control. These transitions will
occur every 2 to 4 hours. You will be asked to complete another PVT test each time you
transition.
7. You will be allowed to leave the driver’s seat while the automated CMV is in control. You
will be allowed to read, eat, look at your phone, watch TV, etc. when the automated CMV
is in control. You will not be allowed to leave the building.
8. The researcher will routinely ask you if you are experiencing any symptoms of Simulator
Sickness. You can also alert the researcher should you begin to be aware of symptoms.
9. Complete a post-study ADS experience & perceptions questionnaire.

What happens if I say yes, but I change my mind later?
You can leave the research at any time, for any reason, and it will not be held against you.
If you decide to leave the research, let the researcher know so that they can compensate you for your
participation up to the time of withdrawal.
You are also free to not answer any questions that you choose without penalty.
If you are experiencing symptoms of simulator sickness, we will ask you to stay at VTTI until you are
symptom free for 20 minutes.

Is there any way being in this study could be bad for me? (Detailed Risks)
There are some minor risks and discomforts to which you may be exposed to in volunteering for this
research. These risks include:
1. Possible discomfort associated with Simulator Sickness. Symptoms may include fatigue,
headache, eye strain, difficulty focusing, increased salivation, dry mouth, sweating, nausea,
difficulty concentrating, fullness of head, blurred vision, dizziness, vertigo, nausea and upset
stomach. This is similar to what someone may experience after riding an amusement park ride
or when using virtual reality headsets.
2. The risk of completing the questionnaires is like completing office paperwork. However, there
is also risk associated with disclosing illegal behavior on two of the questionnaires.
3. Due to the length of the sessions, you may become fatigued.
The following precautions will be taken to ensure minimal risk to the participants:

Virginia Tech Institutional Review Board Protocol No. 23-238
Approved March 7, 2023

VT SBE Informed Consent version 1.0.0
3 of 6

Consent to Take Part in a Research Study
1. You will be driving in a simulator instead of live traffic situations to prevent harm from crashes
or other hazards while driving.
2. You will be given breaks from the driving simulator to ensure minimum discomfort. You will
be allowed to stop the simulator session at any time if you feel physical discomfort.
3. If you begin to experience symptoms of simulator sickness, you will be monitored by an
experimenter until you have been symptom free for 20 minutes and can leave VTTI.
4. You may stop participating in the study at any time. You may also choose to skip questions on
the questionnaires.
5. If you live within 30 miles of VTTI, you will be required to accept a ride to and from VTTI. If
you live further than 30 miles of VTTI, you will be offered a local hotel room for one night and
a ride to and from the hotel.

What Information and Data Will Be Collected?
INFORMATION
1. Contact information includes your name, address, email address, phone numbers, and similar
information used to contact you when needed. It will be stored securely in electronic form
during the study and destroyed one year after the study is complete. This information will not
be used in any research or analysis.
2. Auxiliary study information includes your Social Security Number and information that you
provide on the W9 form. Virginia Tech requires this to compensate you for your participation.
This information will not be linked to your study data and will not be used in any research or
analysis.
DATA (Used for Research)
1. Driver data includes your answers to the questionnaires and the PVT. These data will not
contain your name or any identifying information and will be used in analyses, both on their
own and in combination with the driving data. These data will be stored securely in electronic
form indefinitely.
2. Driving and eye tracking data includes the data we collect from the simulator and eye
tracking device while you are “driving”, including video data, and sensor data. This
information will contain video of your face. These data will be stored securely in electronic
form indefinitely.
How Information and Data are Collected
The simulator will capture data on your driving as well as video of the screens and you as a driver.
Similarly, eye tracking data will be collected via a small camera in the simulator. Questionnaires and
PVT will be collected electronically using a VTTI tablet.

What happens to the information collected for the research?
We will make every effort to limit the use and disclosure of your personal information, including
research study records, only to people who have a need to review this information. We cannot promise
complete confidentiality. Organizations that may inspect and copy your information include the IRB,
Human Research Protection Program, and other authorized representatives of Virginia Tech.

Virginia Tech Institutional Review Board Protocol No. 23-238
Approved March 7, 2023

VT SBE Informed Consent version 1.0.0
4 of 6

Consent to Take Part in a Research Study
We will separate your private information from data that are collected during this research; deidentified data (which cannot be associated with your identity) could be used for future research
studies or distributed to another investigator for future research studies without your additional
informed consent.
We expect the driver data and driving data from this study to be useful for many years after the study is
over, therefore, we plan to keep and use it indefinitely. It is expected that other researchers beyond the
original study team identified in this form as well as industry partners may also find the data and
results of this study useful. We will allow these individuals to use the data under the following
conditions:
1. Data containing Personally Identifying Information (PII): These data contain information
that could be used to personally identify you. Examples of PII are images of your face. PII will
not be released outside the research team. However, other researchers may be granted
temporary access to the data in a secure environment.
a. VTTI researchers wishing to use data containing PII will be required to submit proof of
IRB approval. These researchers will only be allowed access to view these data in a
secure environment.
b. Researchers outside VTTI will be required to submit proof of IRB approval and sign a
data use license assuring that they will extend the same privacy protections to your PII
that are outlined in this form. These researchers will only be allowed to access these
data in a secure environment or in adherence with National Institutes of Health (NIH)
guidelines.
2. Data not containing PII: These data do not contain any information that could be used to
personally identify you.
a. VTTI researchers will have access to this data.
b. Researchers outside VTTI may use data that does not contain PII after they sign a data
use license.
c. This data may also be posted online for public use in the future.
The results of this research study may be presented in summary form at conferences, in presentations,
reports to the sponsor, and academic papers. Additionally, video collected during your study session
may be included in presentations at conferences. Videos used in presentations will not contain any
information that can be used to identify you. A variety of technologies will be used to blur your face,
replace it with it with an avatar, remove or distort audio, etc.

Can I be removed from the research without my, OK?
The person in charge of the research study or the sponsor can remove you from the research study
without your approval. Possible reasons for removal include the research sponsor deciding to suspend
or cancel the study, uncooperative behavior, or you experience symptoms of simulator sickness.

What else do I need to know?
This research is being funded by the Federal Motor Carrier and Safety Administration (FMCSA).
Any expenses accrued for seeking or receiving medical or mental health treatment will be your
responsibility and not that of the research project, research team, or Virginia Tech.

Virginia Tech Institutional Review Board Protocol No. 23-238
Approved March 7, 2023

VT SBE Informed Consent version 1.0.0
5 of 6

Consent to Take Part in a Research Study
If you agree to take part in this research study, we will provide you with $975 at the end of the session.
If you withdraw from the study in the middle of a session, you will be compensated for the time you
participated at the pro-rated rate of $50 per hour.
Compensation is provided via a prepaid MasterCard. Please allow one full business day for the
MasterCard to be activated. Once activated, this card cannot be used past its expiration date. As stated
in the ClinCard FAQ documentation you receive, the issuing bank will begin subtracting a monthly
service fee of $4.50 after three months of inactivity.
Signature Block for Capable Adult
Your signature documents your permission to take part in this research. We will provide you with a
signed copy of this form for your records.

Signature of subject

Date

Printed name of subject
Signature of researcher obtaining consent

Date

Printed name of researcher obtaining consent

Virginia Tech Institutional Review Board Protocol No. 23-238
Approved March 7, 2023

VT SBE Informed Consent version 1.0.0
6 of 6


File Typeapplication/pdf
File Modified2024-04-02
File Created2024-04-02

© 2024 OMB.report | Privacy Policy